FDA.reportPublic FDA data

Unisom SleepTabs

Manufacturer
Chattem, Inc.
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:51:13

Label at a glance#

ProductUnisom SleepTabs
Active ingredientDOXYLAMINE SUCCINATE
Label structure10 sections

Dosage and administration

■ adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor ■ children under 12 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)         

OTC - ACTIVE INGREDIENT SECTION

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use   

INDICATIONS & USAGE SECTION

■ helps to reduce difficulty in falling asleep

Warnings   

WARNINGS SECTION

See carton for complete warnings 

Do not use

OTC - DO NOT USE SECTION

■ in children under 12 years of age

■ with any other product containing doxylamine

■ unless you have time for a full night’s sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

■ sedatives or any other sleep-aid

■ tranquilizers

■ any other antihistamines

■ any other drugs

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic beverages

■ do not drive a motor vehicle or operate machinery

■ take only at bedtime

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor

■ children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

■ TAMPER EVIDENT : DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING  

■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN    

■ store at controlled room temperature 20º-25ºC (68º-77ºF) 

■ see end flap for expiration date and lot number 

■ use by expiration date on package 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2798 Monday - Friday 8am-6pm ET

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unisom
SleepTabs
Doxylamine succinate tablets, 25 mg
NIGHTTIME SLEEP-AID

Unisom SleepTabs Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AIDUnisom SleepTabs Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN1
1101448Unisom SleepTabs 25 MG Oral TabletPSN1
1101448doxylamine succinate 25 MG Oral Tablet [Unisom]SBD1
1101446doxylamine succinate 25 MG Oral TabletSCD1
1101448Unisom 25 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0608-0Unisom SleepTabs16 in 1 BLISTER PACKTABLET161
41167-0608-0Unisom SleepTabs1 in 1 CARTONTABLET11
41167-0608-1Unisom SleepTabs1 in 1 CARTONTABLET11
41167-0608-1Unisom SleepTabs32 in 1 BOTTLETABLET321
41167-0608-2Unisom SleepTabs1 in 1 CARTONTABLET11
41167-0608-2Unisom SleepTabs48 in 1 BOTTLETABLET481
41167-0608-3Unisom SleepTabs1 in 1 CARTONTABLET11
41167-0608-3Unisom SleepTabs80 in 1 BOTTLETABLET801
41167-0608-4Unisom SleepTabs4 in 1 BLISTER PACKTABLET41
41167-0608-4Unisom SleepTabs1 in 1 CARTONTABLET11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-060841167-0608-4, 41167-0608-0, 41167-0608-1, 41167-0608-2, 41167-0608-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040564-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2784e616aacf4f…
2026-08-18 06:07:402026-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.7ae32d74-76a0-47e2-9e5c-812426413c4e2026-03-25WarningsExact identifier
ndc (package): 41167-0608-3
ndc (package): 41167-0608-2
ndc (package): 41167-0608-0
ndc (package): 41167-0608-1
ndc (package): 41167-0608-4
ndc (product): 41167-0608
ndc11 (package): 41167060803
ndc11 (package): 41167060800
ndc11 (package): 41167060804
ndc11 (package): 41167060801
ndc11 (package): 41167060802
spl id: d16a629c-c038-4ab2-a330-9df512db0288
spl set id: 7ae32d74-76a0-47e2-9e5c-812426413c4e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.